Search

In France, hospital cell therapy units have not been authorised to routinely produce chimeric antigen receptor T lymphocytes (CAR-T cells), which would then be referred to as academic CAR-T cells. CAR-T cells are classified as advanced therapy medicinal products and correspond to genetically modified T lymphocytes ex vivo. The CAR-T cell production process is complex and requires scientific and technical expertise to meet the acceptance criteria of the pharmaceutical quality system. The most commonly used method for genetically modifying T lymphocytes is viral transduction (lentiviral or retroviral), which requires prior access to a batch of good manufacturing practice (GMP) grade viral vector. Because of its cost, this reagent is the main limiting factor for developing CAR-T cells. A CAR-T cell produced by an industrial company is expensive (around €350,000 per injection) and the time taken by the manufacturer to make it available to the clinician can vary from three to five weeks. By meeting the economic and ecological challenges, can academic structures improve access to CAR-T cells? In this article, we present the elements necessary for the feasibility of setting up CAR-T cell production in an academic structure., (Copyright © 2023 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

The health service is closely linked to many entities within the fire and rescue service. This makes it possible to be a force for proposals on the implementation of measures for the safety of all but also on themes related to well-being at work. This facet is exciting with many human and technical interactions., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Biologics are tremendously efficacious biological molecules that have enabled the treatment of many life-threatening diseases, which have previously been hard to treat. Biosimilars, also known as "follow-on biologics", are highly similar versions of another already approved biologic, called the Reference Product. The European Union has been a pioneer in the regulation of biosimilars. WHO guideline on evaluation of biosimilars published in 2009 was an important landmark in biosimilar regulations worldwide, and several countries have adopted its principles in the development of their own regulatory pathway for the approval of biosimilars. Most countries in the Middle East North Africa (MENA) region still lack official and scientific guidelines for biosimilar approval pathways. This article explores the regulatory situation of biosimilar registration pathways in Algeria and describes the progress made and the regulatory landscape changes for biosimilars in Algeria during the past ten years. Our findings indicate that the development of biosimilar regulation in Algeria went through three major phases between 2006 and 2021, during which there has been much progress in drafting guidance documents for biosimilars. Since 2016, Algeria has used the EMA, FDA and WHO guidelines as the basis for approval of several biosimilars and no national guidelines or regulations have been adopted to date. Additionally, there has been no regulation on substitution/interchangeability. The Algerian regulatory authority has gained considerable experience with approval and use of increasingly complex biosimilars over the past 5 years and has the potential to create its own biosimilar-specific regulatory pathway in the near future., (Copyright © 2021 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Various definitions have been proposed to describe Medical Nutrition Therapy (MNT). Broadly, MNT encompasses the provision of nutrition information and advice aimed to prevent, treat, and/or manage health conditions. In Canada, the provision of such information and advice is unregulated, thus allowing anyone to provide MNT services regardless of their education and training. This inevitably poses risks of harm such as the provision of unsafe and/or ineffective nutrition advice as well as delayed evidence-based treatment. Canadian research has further demonstrated that the general public is unable to properly differentiate between regulated, evidence-based nutrition providers (registered dietitians) and those who are unregulated. Therefore, the public is at risk. To reduce nutrition misinformation and ultimately improve the health and well-being of the public, the objective of this paper is, first, to propose a standardized definition of MNT for use across Canada and, second, to propose province- and territory-specific legislative amendments for the regulation of MNT throughout the country. We also present an opposing perspective to the proposed viewpoint. Ultimately, health care regulation across the country requires an overhaul before we expect that nutrition information and advice communicated to the public may be consistently evidence based.

For the National Association of Paramedic School Directors, it is necessary to have reliable data in order to participate in the development of public health policies, but also to demonstrate the importance of investing in primary care through nursing leadership, training and competence in the service of populations. In France, nursing training capacities are increasing, university recognition is underway, and efforts have been made to finance training and increase salaries. These orientations need to be strengthened at the risk of not guaranteeing the stability of the workforce in the care sector., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Three key ideas emerge from the World Health Organization's 2020 report on the state of the world's nursing workforce: invest in education, engage in employment, and develop leadership. The Nursing and Management Education Agreement Committee responds and shares its thoughts on some of the recommendations identified in this report., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Radiotherapy alone or in association with systemic treatment plays a major role in the treatment of head and neck tumours, either as a primary treatment or as a postoperative modality. The management of these tumours is multidisciplinary, requiring particular care at every treatment step. We present the update of the recommendations of the French Society of Radiation Oncology on the radiotherapy of head and neck tumours from the imaging work-up needed for optimal selection of treatment volume, to optimization of the dose distribution and delivery., (Copyright © 2021 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France., (Copyright © 2021. Published by Elsevier Masson SAS.)

We present an update of the French society of oncological radiotherapy recommendation regarding indication, doses, and technique of radiotherapy for intrathoracic metastases. The recommendations for delineation of the target volumes and critical organs are detailed., (Copyright © 2021 Société française de radiothérapie oncologique (SFRO). Published by Elsevier Masson SAS. All rights reserved.)

Objective: The objective was to take stock of the regulation of clinical trials in Mali., Material and Methods: This was a descriptive cross-sectional study carried out of the September 1 to December 15, 2019. It consisted of a literature search and a survey in research centers, ethics committees and regulatory structures in Mali., Results: In 2019, there were 15 clinical trials authorized and conducted by three research centers, including 12 vaccines and 3 drugs trials all approved by an ethics committee. The legal framework for clinical trials is governed in Mali by two texts, one legislative and the other regulatory. They provide for the authorization, suspension or prohibition of biomedical research by the minister in charge of Health. The shortcomings identified relate to the low recovery and lack of evaluation of pharmacovigilance data, the scarcity of site inspections and especially the absence of a technical committee for regulatory evaluation of files at the Pharmacy and Medicines Department (DPM)., Conclusion: The strengthening of the legal framework is, more than ever, necessary to ensure the protection of the rights, safety and well-being of research subjects in a context of increasing relocation of clinical trials to our countries., (Le comité de rédaction se réserve le droit de renvoyer aux auteurs avant toute soumission à l'avis des lecteurs les manuscrits qui ne seraient pas conformes à ces modalités de présentation. En outre il leur conseille de conserver un exemplaire du manuscrit, des figures et des tableaux.)

The usefulness and efficiency of intensive care units have been widely highlighted in recent months. The regulatory provisions that structure and frame their organisation and operation have contributed to this. But they must evolve and be accompanied by other improvement actions, to make up for the delays and insufficiencies revealed or exacerbated by the pandemic., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

The care and referral of patients with psychiatric conditions is a perilous process. It combines the need for care with respect for individual freedom. Knowledge of the different legal frameworks is thus necessary for psychiatric care at the request of a third party, care without request of a third party within the framework of a procedure for imminent danger, and finally for the injunction of psychiatric care on the decision of a State representative. These are necessary prerequisites for practising in an emergency structure., (Copyright © 2021. Published by Elsevier Masson SAS.)

Objectives: The existence of borderline products between the status of a medicinal product and other less regulated products allows some products to have different statuses or even to change from one status to another. In order to quantify these changes, a review of medicines that have changed from drug status to other statuses (medical device, cosmetic product or food supplement) in France between 2010 and 2019 was performed., Method: The lists of medicinal products with archived or revoked marketing authorization (MA) from the French National Authority's Register of Medicinal Products were analyzed in order to identify the medicinal products withdrawn from the market between January 1, 2010 and September 30, 2019 that could be considered as products with a "potential for status change". Then, we searched on the official websites of the MA holders and other firms, for a possible return to the market with a different status, marketed by the same firm (self-change of status) or a different firm (hetero-change of status)., Results: Out of a list of 206 drugs identified as "with potential for status change", we detected a total of 101 status changes, including 36 auto-changes and 65 hetero-changes. These changes mainly concern vitamin or herbal drugs later marketed as food supplements (30 cases of auto-changes and 60 cases of hetero-changes). There are also 6 cases of switching to cosmetic product and 5 cases of switching to medical device., Conclusion: The existence of no clear distinction between the different statuses of health products facilitates their status changes. The increasing shift from "medicines" to less regulated products, the trivialization of their use by the public and their increasing consumption make them a fundamental issue of social pharmacology, requiring to raise the awareness of consumers and health professionals., (Copyright © 2020 Société française de pharmacologie et de thérapeutique. All rights reserved.)

Since 2004, procedures which can be carried out by nurses have no longer been subjet to a single global decree and now feature in different legislative and/or regulatory articles. Since 2006, several laws and decrees have expanded the scope of nursing practice, but the lists of authorised procedures for a large part of the profession have not been updated, except for theatre nurses and nurse anaesthetists. The obsolescence of these regulatory lists is out of step with the technical evolution of care, the organisation of the health system and patients' needs., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Time is a key element of the nursing research process, notably because it is lacking in daily life and is subject to strict regulations. Engage in a nursing research project thereby forces the researcher to review the time available, to rethink nursing practice. It can therefore prove to be a useful tool in the organisation of are and the improvement of practices., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

In France, clinical research involving human beings is regulated by the Jardé's law since November 2016. The law distinguishes interventional and non-interventional studies. Both need to be authorized by a Persons Protection Committee. Studies performed on medical data collected during standard clinical care are not considered as studies involving human beings. Medical data are personal data. French Data Protection Authority National has an important role, guarantying the respect of regulation on personal data. We summarize in this article the different types of studies and the role of regulatory authorities., (Copyright © 2019 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier Masson SAS. All rights reserved.)

Introduction: Equine infectious anaemia (EIA) is a sporadic viral disease in many countries. Every single case has, however, a dramatic impact: infected animals have to be put down, and quarantine restrictions on horse movements lasting three months lead to substantial economic losses. In Switzerland, the mandatory notification was introduced in 1994 in order to facilitate international traffic. A year later, the "new" Ordinance on epizootics of 1995 classified EIA as a "disease to be eradicated". An infected polo horse in the canton of Argovia in summer 2017 thus represented Switzerland's first official case. It served as a starting point to review the legal frameworks of the EU and Switzerland. Recent publications suggest that there might be some potential to optimize the current diagnostic protocols. EIA is transmitted by virus-containing blood and blood products. Introductions in previously disease-free regions are mostly due to human activities, while blood feeding insects as horse flies or other biting flies act as mechanical vectors only locally within some 100 meters. As before, the new EU Regulations governing animal health do not prescribe national monitoring and control plans, allowing member states to shape them according to their particular situation. However, they have to ensure that equids intended for intracommunity movements comply with specific guarantees. In this context, a fine-tuning of current international standards seems conceivable. Mandatory testing preceding each movement would not be a proportionate option even for the future. Regardless their final wording, it would be a great step for all the actors involved in animal traffic if it were possible to adopt rules that are accepted and uniformly implemented by all competent authorities at national, regional and local level. However, the official system will never be able to guarantee absolute safety. Since there are neither effective vaccines nor treatment protocols, it is crucial that all owners, stablehands, veterinarians, associations, and organizers of horse contests are aware of the disease risks, minimizing them as far as possible by adequate biosecurity measures.

Aquaculture will continue to grow, but environmental constraints will interact with changing consumer profiles and regulatory frameworks such that future growth will look somewhat different from the trajectories of the past 30 years. Availability and price of land, fresh water, feeds and energy, and concerns about pollution and the introduction of non-native species will be major constraints to expansion. New technology will evolve in response to these concerns. This new technology will be based on the principle of sustainable intensification so as to reduce the environmental footprint per unit of production and limit volatility in markets precipitated by disease and other production system problems. Markets and consumer demand will be reflected in the economics of the industry under more sophisticated regulatory regimes. More sustainable sources of the proteins and oils in fish diets, improved genetic management, and better health and production systems will continue to underpin the expansion of aquaculture into the 21st century and beyond.

For twenty years, the author has worked as an advanced nurse practitioner in a large general practice in the north of England. In pioneering times for these new nursing roles, she completed her training at university and alongside her doctor colleagues. In this article she looks back at this highlight of her career and describes the deployment of this practice in the United Kingdom., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

The scope of practice for nurses has evolved significantly over the past four decades. It is striking to note that this development has been written almost exclusively in a single section of the law, the drafting of which has been completed over time. Knowing accelerations and slowdowns, however, it follows a general trend towards increasing recognition of the major role of nurses in the health system., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Regulatory Framework for Car-T Cells: HOW CAN FRENCH HEALTHCARE PROVIDERS ADAPT THEIR ORGANIZATION TO REQUIREMENTS FOR MANUFACTURING AND DELIVERY OF THESE INNOVATIVE CELL-BASED MEDICINAL PRODUCTS?: More than five years after the first US publications reporting a significant rate of clinical responses in patients with high-risk or advanced CD19+ lymphoid malignancies, access to treatment with CAR-T Cells at European hospitals in general and at French hospitals in particular remains limited. One - and not the least - hurdle lay in the need to set up a complex and unprecedented organization that complies with European regulations on Advanced Therapy Medicinal Products as well as with national (French) regulations. We here review the organizational framework for two situations: delivery and administration of industry-manufactured CAR-T Cells as well as engineering and distribution of CAR-T Cells produced as investigational drugs to be evaluated in the context of clinical research protocols. Cet article fait partie du numéro supplément Les cellules CAR-T : une révolution thérapeutique ? réalisé avec le soutien institutionnel des partenaires Gilead : Kite et Celgene., (© 2018 Société Française du Cancer. Publié par Elsevier Masson SAS. Tous droits réservés.)

The last decade has contributed to the emergence of telemedicine. Legislation and regulations, new tools, efficient networks and regional deployments have all played their part in its growth. There are several regional solutions, often experimental. The implementation of telemedicine services nevertheless comes up against obstacles which concern all specialities, including cardiology., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

The voluntary and unpaid blood donation is recommended by all international authorities (WHO, Council of Europe, ISBT, EBA), because it represents the best way of aiming towards self-sufficiency in blood products of all kinds, while preserving an optimal level of quality and safety for recipients as for donors. Still infrequent in many developing countries it tends to develop. However, the objective assigned by the WHO to reach 100% of unpaid and voluntary blood donations in 2020 appears ambitious, in particular for the collection of plasma intended to the splitting industry. The close evaluation of European directives concerning the donation of human body elements should allow harmonization of practices by Member States., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

While, in France, various health professionals are authorised to prescribe, they approach this activity in a different way, depending on the professional category to which they belong. The areas and products concerned are specific to each profession, and inevitably evolve. This article presents the different perspectives of a doctor, a midwife and a nurse., (Copyright © 2016. Published by Elsevier Masson SAS.)

The purpose of this article is to describe the regulatory framework of the radiotherapy practice in France, the external irradiation and brachytherapy process and the guidelines for patient follow-up., (Copyright © 2016 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.)

The purpose of this article is to describe the specificities of paediatric radiation oncology: cancer types, radiotherapy indications, techniques, organisation and reglementary framework., (Copyright © 2016. Published by Elsevier SAS.)

It has been a long road for complementary medicines from their use in secrecy just a few decades ago to the first University Congress for Complementary Medicines held in Nice in December 2015. Complementary medicines are now used in hospitals, have been granted a legal framework and recognised training. They are called for by patients., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

Dressings must be prescribed as accurately as possible, whether the prescription is written by a nurse or by a doctor. The pharmacist is then able to dispense the exact product prescribed. Knowledge of the different classes of dressings and their indications ensures the adapted management of chronic and acute wounds., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Smoking is the first avoidable cause of morbidity and mortality. It is estimated that there were around 14 million smokers in France in 2012 and that smoking results in 70,000 deaths per year. All types of interventions reducing with efficacy the incidence and prevalence of smoking are to consider in prolonging life expectancy. Electronic cigarettes (e.cig.) are a social phenomenon but they also are a system delivering pharmacologically active substances; their use concerns today several millions of individuals in France. By this fact, it became important for clinical practitioners to acquire some knowledge about e. cig. Most of the e.cig. contains nicotine, thus, e.cig. are now called in the medical literature as electronic nicotine delivery system (ENDS). It is highly plausible that ENDS, which are, as of today, consumer products and not health products, deliver nicotine with a good bioavailability and could, if largely used, help to reduce smoking prevalence. However, because of current lack of regulations, as of today, the risk/benefit ratio of ENDS as an aid to help smokers quit and their adverse effect profile cannot be established. It is of public health responsibility to promote evidence based knowledge about e.cig. to know with confidence their risk/benefit ratio., (Copyright © 2014 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.)

Objective: To evaluate four household water treatment (HWT) products currently seeking approval for distribution in Haiti, through the application of a recently-developed national HWT product certification process., Methods: Four chemical treatment products were evaluated against the certification process validation stage by verifying international product certifications confirming treatment efficacy and reviewing laboratory efficacy data against WHO HWT microbiological performance targets; and against the approval stage by confirming product composition, evaluating treated water chemical content against national and international drinking water quality guidelines and reviewing packaging for dosing ability and usage directions in Creole., Results: None of the four evaluated products fulfilled validation or approval stage requirements. None was certified by an international agency as efficacious for drinking water treatment, and none had data demonstrating its ability to meet WHO HWT performance targets. All product sample compositions differed from labelled composition by >20%, and no packaging included complete usage directions in Creole., Conclusions: Product manufacturers provided information that was inapplicable, did not demonstrate product efficacy, and was insufficient to ensure safe product use. Capacity building is needed with country regulatory agencies to objectively evaluate HWT products. Products should be internationally assessed against WHO performance targets and also locally approved, considering language, culture and usability, to ensure effective HWT., (© 2014 John Wiley & Sons Ltd.)

Indications of treatment by stereotactic body radiotherapy are dramatically increasing due to new potential indications. The conditions associated with the treatment delivery are multiple. The first step of the process is crucial. It is related to the validation of the indication proposed during the multidisciplinary meeting as regard the evidence-based proof of the concept. These emerging techniques mainly extracranial stereotactic body irradiation do not benefit from long-term evaluation in terms of efficiency as well as normal tissue late toxicities. Priority should be given to prospective independent clinical trials, validated by an independent scientific committee, performed under a relevant and well dedicated multicentric quality assurance program aiming to improve knowledge and selection of indications. The SFRO is still working with others professionals on the definition of the conditions for the implementation of such treatments and actively collaborates with the authorities to define the appropriate conditions to preserve the quality of the treatment delivery under these specific conditions., (Copyright © 2014 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.)

In order to answer statutory requirements and to anticipate the future needs and standards, the EFS is committed, since a few years, in a process of harmonization of its metrology function. In particular, the institution has opted for the skills development by internalizing the metrological traceability of the main critical quantities (temperature, volumetric) measurements. The development of metrology so resulted in a significant increase in calibration and testing activities. Methods are homogenized and improved through accreditations. The investment strategies are based on more and more demanding specifications. The performance of the equipments is better known and mastered. Technical expertise and maturity of the national metrology function today are assets to review in more informed ways the appropriateness of the applied periodicities. Analysis of numerous information and data in the calibration and testing reports could be pooled and operated on behalf of the unique establishment. The objective of this article is to illustrate these reflections with a few examples from of a feedback of the EFS Pyrénées Méditerranée. The analysis of some methods of qualification, the exploitation of the historical metrology in order to quantify the risk of non-compliance, and to adapt the control strategy, analysis of the criticality of an instrument in a measurement process, risk analyses are tools that deserve to be more widely exploited for that discipline wins in efficiency at the national level., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Objectives: To investigate the magnitude and characteristics of the economic burden resulting from acute pesticide poisoning (APP) in South Korea., Methods: The total costs of APP from a societal perspective were estimated by summing the direct medical and non-medical costs together with the indirect costs. Direct medical costs for patients assigned a disease code of pesticide poisoning were extracted from the Korean National Health Insurance Reimbursement Data. Direct non-medical costs were estimated using the average transportation and caregiving costs from the Korea Health Panel Survey. Indirect costs, incurred by pre-mature deaths and work loss, were obtained using 2009 Life Tables for Korea and other relevant literature., Results: In 2009, a total of 11,453 patients were treated for APP and 1311 died, corresponding to an incidence of 23.1 per 100,000 population and a mortality rate of 2.6 per 100,000 population in South Korea. The total costs of APP were estimated at approximately US$ 150 million, 0.3% of the costs of total diseases. Costs due to pre-mature mortality accounted for 90.6% of the total costs, whereas the contribution of direct medical costs was relatively small., Conclusion: Costs from APP demonstrate a unique characteristic of a large proportion of the indirect costs originating from pre-mature mortality. This finding suggests policy implications for restrictions on lethal pesticides and safe storage to reduce fatality and cost due to APP., (© 2012 Blackwell Publishing Ltd.)

Aim: The general objective of this study was to agree an inventory of fixtures of clinical trials done in Dakar, in order to make recommendations to improve the quality of clinical trials in Senegal., Method: We have done a survey from mars to may 2007, with investigators of the two biggest Senegalese university teaching hospitals and to the pharmacy management and the ethical committee., Results: Our key results showed: 1) a small participation rate of teachers to clinical trials (11 on 37 interviewed); 2) that the principal sponsor is pharmaceutical industry; 3) that most of investigators have not degree in clinical trials; 4) that most pathologies concerned were malaria and AIDS; 5) that there are regulations related to clinical trials in Senegal., Conclusion: This study shows the necessity to integrate, in Senegal, clinical trials in the curricula of students training., (Copyright © 2008 Société Française de Pharmacologie et de Thérapeutique. Publié par Elsevier Masson SAS.)